BEUDAMED
    FDA Registration Active 🇨🇳 China

    CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD.

    Reg #: 3010612620 · FEI: 3010612620 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD.
    Registration Number
    3010612620
    FEI Number
    3010612620
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou District
    City
    changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K200053

    Owner / Operator

    Firm Name
    Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
    Operator Number
    10059339
    Address
    No.20 Floor, Huajing Building, No.1 Hejing Garden, Zhonglou District
    City
    changzhou
    State
    Jiangsu
    Postal Code
    213000
    Country
    CN
    Correspondent
    Chao Huang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Stapler, Skin QQS
    Laparoscope, General & Plastic Surgery GCJ
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Forceps, Biopsy, Non-Electric FCL
    Endoscopic Irrigation/Suction System OCX
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Endoscopic Bite Block MNK
    Instrument, Surgical, Disposable KDC
    Bougie, Esophageal, And Gastrointestinal, Gastro-Urology FAT
    Trap, Sterile Specimen BYZ
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Endoscope Channel Accessory ODC
    Accessories, Cleaning Brushes, For Endoscope MNL

    Proprietary Names

    Sterile disposable skin stapler Disposable Specimen Retrieval Bag Disposable Grasping Forceps Disposable Biopsy Forceps, Disposable Rotatable Biopsy Forceps Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing Air/Water Channel Cleaning Adapter, Suction Cleaning Adapter Disposable Bite Blocks Skin Staple Removers Dilators Polyp Traps Non-vascular Guidewires Disposable Endoscope Valves System Cleaning Brushes for Endoscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device